Exploring effects of presurgical weight loss among women with stage 0–II breast cancer: protocol for a randomised controlled feasibility trial
Identifieur interne : 001076 ( Main/Exploration ); précédent : 001075; suivant : 001077Exploring effects of presurgical weight loss among women with stage 0–II breast cancer: protocol for a randomised controlled feasibility trial
Auteurs : Yuko Tsuruta [États-Unis] ; Laura Q. Rogers [États-Unis] ; Helen Krontiras [États-Unis] ; William E. Grizzle [États-Unis] ; Andrew D. Frugé [États-Unis] ; Robert A. Oster [États-Unis] ; Heidi R. Umphrey [États-Unis] ; Lee W. Jones [États-Unis] ; Maria Azrad [États-Unis] ; Wendy Demark-Wahnefried [États-Unis]Source :
- BMJ Open [ 2044-6055 ] ; 2016.
Abstract
Obesity is a known risk factor for postmenopausal breast cancer and is associated with poorer prognosis for premenopausal and postmenopausal patients; however, the aetiological mechanisms are unknown. Preclinical studies support weight loss via caloric restriction and increased physical activity as a possible cancer control strategy, though few clinical studies have been conducted. We undertook a feasibility trial among women recently diagnosed with stage 0–II breast cancer hypothesising that presurgical weight loss would be feasible, safe and result in favourable changes in tumour markers and circulating biomarkers.
A two-arm randomised controlled trial among 40 overweight or obese women, newly diagnosed with stage 0–II breast cancer and scheduled for surgery was planned. The attention control arm received upper body progressive resistance training and diet counselling to correct deficiencies in nutrient intake; the experimental arm received the same plus counselling on caloric restriction and aerobic exercise to achieve a weight loss of 0.68–0.919 kg/week. In addition to achieving feasibility benchmarks (accruing and retaining at least 80% of participants, and observing no serious adverse effects attributable to the intervention), we will explore the potential impact of an acute state of negative energy balance on tumour proliferation rates (Ki-67), as well as other tumour markers, serum biomarkers, gene expression, microbiome profiles and other clinical outcomes (eg, quality of life). Outcomes for the 2 study arms are compared using mixed models repeated-measures analyses.
Ethics approval was received from the University of Alabama at Birmingham Institutional Review Board (Protocol number F130325009). Study findings will be disseminated through peer-reviewed publications. Given that this is one of the first studies to investigate the impact of negative energy balance directly on tumour biology in humans, larger trials will be pursued if results are favourable.
Url:
DOI: 10.1136/bmjopen-2016-012320
PubMed: 27633639
PubMed Central: 5030610
Affiliations:
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Rogers</name><affiliation wicri:level="1"><nlm:aff id="af1"><addr-line>Department of Nutrition Sciences</addr-line>,<institution>University of Alabama at Birmingham</institution>,<addr-line>Birmingham, Alabama</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Krontiras, Helen" sort="Krontiras, Helen" uniqKey="Krontiras H" first="Helen" last="Krontiras">Helen Krontiras</name><affiliation wicri:level="1"><nlm:aff id="af2"><addr-line>Department of Surgery</addr-line>,<institution>University of Alabama at Birmingham</institution>,<addr-line>Birmingham, Alabama</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Grizzle, William E" sort="Grizzle, William E" uniqKey="Grizzle W" first="William E" last="Grizzle">William E. Grizzle</name><affiliation wicri:level="1"><nlm:aff id="af3"><addr-line>Department of Pathology</addr-line>,<institution>University of Alabama at Birmingham</institution>,<addr-line>Birmingham, Alabama</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Fruge, Andrew D" sort="Fruge, Andrew D" uniqKey="Fruge A" first="Andrew D" last="Frugé">Andrew D. Frugé</name><affiliation wicri:level="1"><nlm:aff id="af1"><addr-line>Department of Nutrition Sciences</addr-line>,<institution>University of Alabama at Birmingham</institution>,<addr-line>Birmingham, Alabama</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Oster, Robert A" sort="Oster, Robert A" uniqKey="Oster R" first="Robert A" last="Oster">Robert A. Oster</name><affiliation wicri:level="1"><nlm:aff id="af4"><addr-line>Department of Medicine</addr-line>,<institution>University of Alabama at Birmingham</institution>,<addr-line>Birmingham, Alabama</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Umphrey, Heidi R" sort="Umphrey, Heidi R" uniqKey="Umphrey H" first="Heidi R" last="Umphrey">Heidi R. Umphrey</name><affiliation wicri:level="1"><nlm:aff id="af5"><addr-line>Department of Radiology</addr-line>,<institution>University of Alabama at Birmingham</institution>,<addr-line>Birmingham, Alabama</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Jones, Lee W" sort="Jones, Lee W" uniqKey="Jones L" first="Lee W" last="Jones">Lee W. Jones</name><affiliation wicri:level="1"><nlm:aff id="af6"><addr-line>Department of Medicine</addr-line>,<institution>Memorial Sloan Kettering Cancer Center</institution>,<addr-line>New York, New York</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Azrad, Maria" sort="Azrad, Maria" uniqKey="Azrad M" first="Maria" last="Azrad">Maria Azrad</name><affiliation wicri:level="1"><nlm:aff id="af1"><addr-line>Department of Nutrition Sciences</addr-line>,<institution>University of Alabama at Birmingham</institution>,<addr-line>Birmingham, Alabama</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Demark Wahnefried, Wendy" sort="Demark Wahnefried, Wendy" uniqKey="Demark Wahnefried W" first="Wendy" last="Demark-Wahnefried">Wendy Demark-Wahnefried</name><affiliation wicri:level="1"><nlm:aff id="af1"><addr-line>Department of Nutrition Sciences</addr-line>,<institution>University of Alabama at Birmingham</institution>,<addr-line>Birmingham, Alabama</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">BMJ Open</title><idno type="eISSN">2044-6055</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Introduction</title><p>Obesity is a known risk factor for postmenopausal breast cancer and is associated with poorer prognosis for premenopausal and postmenopausal patients; however, the aetiological mechanisms are unknown. Preclinical studies support weight loss via caloric restriction and increased physical activity as a possible cancer control strategy, though few clinical studies have been conducted. We undertook a feasibility trial among women recently diagnosed with stage 0–II breast cancer hypothesising that presurgical weight loss would be feasible, safe and result in favourable changes in tumour markers and circulating biomarkers.</p></sec><sec><title>Methods and analysis</title><p>A two-arm randomised controlled trial among 40 overweight or obese women, newly diagnosed with stage 0–II breast cancer and scheduled for surgery was planned. The attention control arm received upper body progressive resistance training and diet counselling to correct deficiencies in nutrient intake; the experimental arm received the same plus counselling on caloric restriction and aerobic exercise to achieve a weight loss of 0.68–0.919 kg/week. In addition to achieving feasibility benchmarks (accruing and retaining at least 80% of participants, and observing no serious adverse effects attributable to the intervention), we will explore the potential impact of an acute state of negative energy balance on tumour proliferation rates (Ki-67), as well as other tumour markers, serum biomarkers, gene expression, microbiome profiles and other clinical outcomes (eg, quality of life). Outcomes for the 2 study arms are compared using mixed models repeated-measures analyses.</p></sec><sec><title>Ethics and dissemination</title><p>Ethics approval was received from the University of Alabama at Birmingham Institutional Review Board (Protocol number F130325009). Study findings will be disseminated through peer-reviewed publications. Given that this is one of the first studies to investigate the impact of negative energy balance directly on tumour biology in humans, larger trials will be pursued if results are favourable.</p></sec><sec><title>Trial registration number</title><p><ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT02224807?term=NCT02224807&rank=1">NCT02224807</ext-link>; Pre-results.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Siegel, Rl" uniqKey="Siegel R">RL Siegel</name></author><author><name sortKey="Miller, Kd" uniqKey="Miller K">KD Miller</name></author><author><name sortKey="Jemal, A" uniqKey="Jemal A">A Jemal</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Susan, G K" uniqKey="Susan G">G K Susan</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Eheman, C" uniqKey="Eheman C">C Eheman</name></author><author><name sortKey="Henley, 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Clark</name></author><author><name sortKey="Coleman, E" uniqKey="Coleman E">E Coleman</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bandura, A" uniqKey="Bandura A">A Bandura</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Caporaso, Jg" uniqKey="Caporaso J">JG Caporaso</name></author><author><name sortKey="Lauber, Cl" uniqKey="Lauber C">CL Lauber</name></author><author><name sortKey="Walters, Wa" uniqKey="Walters W">WA Walters</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Daft, Jg" uniqKey="Daft J">JG Daft</name></author><author><name sortKey="Ptacek, T" uniqKey="Ptacek T">T Ptacek</name></author><author><name sortKey="Kumar, R" uniqKey="Kumar R">R Kumar</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Kumar, R" uniqKey="Kumar R">R Kumar</name></author><author><name sortKey="Eipers, P" uniqKey="Eipers P">P Eipers</name></author><author><name sortKey="Little, Rb" uniqKey="Little R">RB Little</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rizza, W" uniqKey="Rizza W">W Rizza</name></author><author><name sortKey="Veronese, N" uniqKey="Veronese N">N Veronese</name></author><author><name sortKey="Fontana, L" uniqKey="Fontana L">L Fontana</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>États-Unis</li></country></list><tree><country name="États-Unis"><noRegion><name sortKey="Tsuruta, Yuko" sort="Tsuruta, Yuko" uniqKey="Tsuruta Y" first="Yuko" last="Tsuruta">Yuko Tsuruta</name></noRegion><name sortKey="Azrad, Maria" sort="Azrad, Maria" uniqKey="Azrad M" first="Maria" last="Azrad">Maria Azrad</name><name sortKey="Demark Wahnefried, Wendy" sort="Demark Wahnefried, Wendy" uniqKey="Demark Wahnefried W" first="Wendy" last="Demark-Wahnefried">Wendy Demark-Wahnefried</name><name sortKey="Fruge, Andrew D" sort="Fruge, Andrew D" uniqKey="Fruge A" first="Andrew D" last="Frugé">Andrew D. Frugé</name><name sortKey="Grizzle, William E" sort="Grizzle, William E" uniqKey="Grizzle W" first="William E" last="Grizzle">William E. Grizzle</name><name sortKey="Jones, Lee W" sort="Jones, Lee W" uniqKey="Jones L" first="Lee W" last="Jones">Lee W. Jones</name><name sortKey="Krontiras, Helen" sort="Krontiras, Helen" uniqKey="Krontiras H" first="Helen" last="Krontiras">Helen Krontiras</name><name sortKey="Oster, Robert A" sort="Oster, Robert A" uniqKey="Oster R" first="Robert A" last="Oster">Robert A. Oster</name><name sortKey="Rogers, Laura Q" sort="Rogers, Laura Q" uniqKey="Rogers L" first="Laura Q" last="Rogers">Laura Q. Rogers</name><name sortKey="Umphrey, Heidi R" sort="Umphrey, Heidi R" uniqKey="Umphrey H" first="Heidi R" last="Umphrey">Heidi R. Umphrey</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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